Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202407721329710 Date of Approval: 15/07/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of “Yoga like” exercises on mild cognitive disorder in Elderly
Official scientific title Effects of “Yoga like” exercises on mild cognitive disorder in Elderly: a randomized controlled trial
Brief summary describing the background and objectives of the trial Physical activity has proven its efficacy in slowing cognitive decline and improving psychological symptoms associated to cognitive disorder in elderly. While aerobic exercises showed positive effects, those interventions may not be applied due to multiple disabilities in elderly. Other soft exercises with mindful approaches such as Yoga are tried without clearly evidence. The aim of this study is to assess efficacy of “Yoga like” intervention on cognitive and psychological features in patients with mild cognitive impairment. This randomized controlled trail will include patient with mild cognitive impairment able for neurocognitive assessment without a disease that contraindicates deep breathing and extremes postures who will be randomly allocated to an intervention group (IG: Modified Yoga) and a control group (CG: no intervention). The modified Yoga intervention consists of 30 minutes of exercises combining breathing, postures, concentration and meditation, three sessions a week for eight weeks. At baseline and after eight weeks both groups will have the following neuropsychological tests: memory, verbal fluency, problem solving, visuospatial disorder and mood.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/09/2024
Actual trial start date
Anticipated date of last follow up 01/06/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 32
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group No intervention Eight weeks Patients will be advised to continue their routine daily activities with no physical activity 16 Uncontrolled
Experimental Group Yoga like exercises 3 sessions per week 30 minutes per session eight weeks The intervention will include the eight pillars of Yoga applied on a chair. Chair height will be selected to ensure patient comfort and allow patient to rest their feet on the floor with a backrest that allows the patient to rest their back in an aligned position. Sessions will be guided by one therapist including small groups of five patients. The session will begin with slow and deep breathing exercises. Therapist will educate the patient on proper breathing techniques Pranayama (Breath Control). Pranayama involves controlling the breath to improve energy flow and mental clarity. In addition to learning about breathing, the yoga coach will also review the two foundational pillars of yoga, which are: Yama (Universal moral observances) and Niyama (Self-discipline) so during all the session therapist will remind the patient to accept himself, his limitations and his values. Then, the therapist will propose a series of postures of the neck, back and limbs Asanas (Physical postures) on the chair coupled with the same breathing rhythm. The last five minutes will include Pratyahara (Sense withdrawal) and Dharana(Concentration) and finished by Dhyana (Meditation) and Samadhi (Absorption). During the meditation part, the therapist will ask the patient to close their eyes, take wide diaphragmatic breaths, relax the neck, shoulders, hands and toes, release all negative thoughts on the exhalation and welcome positive thoughts and accept the illness. Finally, the therapist will ask the patient to congratulate themselves and express gratitude for all the achievement of the session, and he will remind the patient the interest of self-love. 16
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Aged more than 65 years Having a mini-mental state examination (MMSE) score between 18-23 Normal or corrected-to-normal vision and color perception Able to sit on a chair Cardiovascular or orthopedic conditions that can affect the ability to perform the proposed intervention tasks Heart or respiratory disease that do not allow physical activity Severe cognitive disorder Severe psychiatric disease Medication that affects the posture or the ability to do the exercises Aged: 65+ Year(s) 65 Year(s) 78 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/06/2024 Ethics committee faculty of medicine Sousse
Ethics Committee Address
Street address City Postal code Country
Rue Mohamed Karoui Sousse 4002 Tunisie Sousse 4002 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Episodic memory using the Arabic version of the five-word test Before and immediately after intervention
Secondary Outcome Visuospatial disorders using the clock drawing test Before and immediately after intervention
Secondary Outcome Problem-solving skills using the Tower of Hanoi Test Before and immediately after intervention
Primary Outcome Verbal fluency using the categorical or lexical fluency test Before and immediately after intervention
Secondary Outcome Attention using the Arabic version of the Stroop Color and Word Test Before and immediately after intervention
Secondary Outcome Mood using the 15-item Geriatric Depression Scale Before and immediately after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sahloul university hospital Route ceinture Sousse 4011 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Sahloul hospital Route ceinture Sousse 4050 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Sahloul hospital Route ceinture Sousse 4050 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rihab Moncer rihabmoncer@hotmail.com +21653911717 Route ceinture
City Postal code Country Position/Affiliation
Sahloul 4011 Tunisia University hospital assistant
Role Name Email Phone Street address
Public Enquiries Sonia Jemni jemnisonia@hotmail.com +21699999169 Route ceinture, Sahloul university hospital
City Postal code Country Position/Affiliation
Sahloul 4011 Tunisia Head of department of physical medicine and rehabilitation
Role Name Email Phone Street address
Scientific Enquiries Helmi Ben Saad helmi.bensaad@rns.tn +21698697024 Laboratory of Physiology Faculty of Medicine of Sousse Street Mohamed KAROUI
City Postal code Country Position/Affiliation
Sousse 4000 Tunisia MD Physiology and Functional Explorations
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data , after deidentification (text, tables, figures, and appendices) will be available and will be shared from one year following the publication without end date. individuals and organizations who are engaged in scientific or scholarly research can request these details from habib2197@gmail.com or rihabmoncer@hotmail.com to achieve aims in the approved proposal. Clinical Study Report,Study Protocol As part of our IPD sharing plan, we will make the data collected in the study available in the protocol. Once the data collection phase is complete, interested researchers will have access to the raw, unprocessed data through the provided protocol. Additionally, we will share the statistical details related to the data analysis. The statistical details will be shared one year after publication. Access to the IPD and documents may be granted to individuals or entities engaged in scientific or scholarly research. Interested researchers or organizations must formally submit a request to habib2197@gmail.com or rihabmoncer@hotmail.com The request should include the purpose of the data usage, a detailed description of the proposed analyses, and any specific requirements. the request will be evaluated to assess the qualifications of the requester, the scientific merit of the proposed analyses, the potential benefits of sharing the data, and the adherence to ethical considerations, data protection, and privacy guidelines. qualifications of the requester, the scientific merit of the proposed analyses, the potential benefits of sharing the data, and the adherence to ethical considerations, data protection, and privacy guidelines. The documents, including study protocols, statistical details, and other relevant materials, will be made available as agreed upon.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information